The BioTrace Medical Tempo Temporary Pacing Lead is indicated for use in temporary intracardiac pacing for a maximum of seven (7) days and is designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

Device Description

The BioTrace Medical Tempo Temporary Pacing Lead is designed for temporary transvenous intracardiac pacing. The lead provides access to the right ventricle via either the femoral vein, subclavian vein or the internal jugular vein approach and may be shaped near the distal end to facilitate delivery. It is a radiopaque, polymeric lead featuring a balloon, active fixation, bipolar electrodes and a soft tip.

AI/ML Overview

The provided text is a 510(k) summary for the BioTrace Medical Tempo Temporary Pacing Lead. It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a formal "table of acceptance criteria" with specific pass/fail thresholds for most tests. Instead, it describes various types of testing performed and then broadly states the outcomes. For the clinical study, it outlines specific endpoints and their achievement.

Acceptance Criteria Category (Implicit)	Specific Test/Evaluation	Reported Device Performance
Material/Mechanical Integrity	Bench Testing:
	- Bond Joint Strength	Results "demonstrate that the technological and performance characteristics of the subject Tempo Temporary Pacing Lead are adequate for its intended use..." (Implies successful completion against internal specifications, but no numerical data is provided).
	- Fatigue Resistance
	- Corrosion Resistance
	- Simulated Use
	- Electrical Resistance
Device Safety	Electrical Safety Testing	Results "demonstrate that the technological and performance characteristics of the subject Tempo Temporary Pacing Lead are adequate for its intended use..." (Implies successful completion).
	Biocompatibility Testing:	Results "demonstrate that the technological and performance characteristics of the subject Tempo Temporary Pacing Lead are adequate for its intended use..." (Implies successful completion for all listed tests).
	- Cytotoxicity, Sensitization, Irritation Reactivity, Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implantation, Hemocompatibility, Hemolysis, Complement Activation, In Vivo Thrombogenicity, Pyrogenicity
Sterility/Packaging	Packaging Validation	Results "demonstrate that the technological and performance characteristics of the subject Tempo Temporary Pacing Lead are adequate for its intended use..." (Implies successful completion).
	Sterilization Validation	Results "demonstrate that the technological and performance characteristics of the subject Tempo Temporary Pacing Lead are adequate for its intended use..." (Implies successful completion).
Shelf Life	Shelf Life Testing (Accelerated Aging)	Results "demonstrate that the technological and performance characteristics of the subject Tempo Temporary Pacing Lead are adequate for its intended use..." (Implies successful completion).
In Vivo Performance (Pre-Clinical)	GLP Animal Testing	Results "demonstrate that the technological and performance characteristics of the subject Tempo Temporary Pacing Lead are adequate for its intended use..." (Implies successful completion).
Clinical Safety & Effectiveness	Clinical Study (The Tempo® Study):
	- Safety Endpoint: Freedom from pericardial effusion requiring intervention and/or echocardiographic evidence of tamponade.	Met in all patients (100%) with no device-related adverse events.
	- Technical Feasibility Endpoint: Intracardiac delivery and pace capture.	Met in 23 patients (92%).
	- Additional Evaluations: Pace capture thresholds (PCT), success of rapid pacing, incidence of dislodgement or sustained ventricular arrhythmias (>30 seconds).	No patient had a sustained ventricular arrhythmia or lead dislodgement. Average final procedural PCT was 0.7±0.5 mA. Rapid pacing was successful in all cases, with no loss of pace capture. In 5 patients, the lead was successfully used post-procedure.

2. Sample Sizes and Data Provenance for the Clinical Study (Test Set):

Sample Size: Twenty-five (25) patients.
Data Provenance:
- Country of Origin: Not explicitly stated, but the study was "multicenter." The manufacturer BioTrace Medical, Inc. is based in San Carlos, California, USA, suggesting the study was likely conducted in the US.
- Study Design: Prospective, multi-center, non-randomized, single-arm study.

3. Number of Experts and Qualifications for Ground Truth for the Test Set:

The document describes a clinical study involving patients and clinical outcomes. The "ground truth" for safety and effectiveness endpoints would be established by the treating physicians and clinical staff involved in the study, and confirmed by documented patient data (e.g., echocardiogram reports, medical records, vital signs, adverse event reporting).
The document does not specify the number of individual "experts" formally adjudicating the clinical trial data in the way one might for an imaging AI study (e.g., a panel of radiologists). The ground truth is the direct clinical observation and measurements from the patient study.

4. Adjudication Method for the Test Set:

For the clinical study, the "adjudication method" is inherent to clinical trial conduct. Data collection would follow a pre-specified protocol, and endpoints like "freedom from pericardial effusion" or "pace capture" would be determined by physicians based on clinical assessment and diagnostic findings.
The document does not mention a specific "x+y" or "3+1" expert adjudication method. This type of adjudication is typically for image-based diagnostic ground truth and is not directly applicable to a study evaluating a physical medical device's functional performance and safety in patients. Clinical trial data collection and review processes serve this purpose.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
This study evaluates a physical medical device (temporary pacing lead) in patients, not an AI algorithm assisting human readers in interpreting medical images. Therefore, the concept of human readers improving with AI assistance is not applicable here.

6. Standalone Performance (Algorithm Only):

This is not an AI algorithm. It is a physical medical device (a temporary pacing lead). Therefore, the concept of "standalone (i.e. algorithm only without human-in-the loop performance)" is not applicable. The device's performance is intrinsically linked to its use by a clinician.

7. Type of Ground Truth Used for the Clinical Study:

The ground truth for the clinical study was based on clinical outcomes and direct physiological measurements in patients.
- Safety Ground Truth: Absence of pericardial effusion requiring intervention, absence of echocardiographic evidence of tamponade, absence of device-related adverse events.
- Effectiveness/Feasibility Ground Truth: Successful intracardiac delivery, successful pace capture, measured pace capture thresholds (PCT), visual confirmation of no lead dislodgement, and assessment of sustained ventricular arrhythmias.

8. Sample Size for the Training Set:

This document describes a regulatory filing for a physical medical device. It does not mention any "training set" in the context of an AI/machine learning model. The device design and verification would have relied on engineering principles, predicate device comparisons, and pre-clinical testing, not a data training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established:

As there is no "training set" for an AI/ML algorithm mentioned, this question is not applicable. The equivalent for a physical device would be the design specifications, pre-clinical testing, and manufacturing quality controls, where "ground truth" is defined by engineering standards and functional requirements.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 25, 2016

Bio Trace Medical, Inc. Laura Dietch President and CEO 831 Bransten Rd, Suite L San Carlos, California 94070

Re: K160260

Trade/Device Name: Tempo Temporary Pacing Lead Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent Or Temporary Pacemaker Electrode Regulatory Class: Class II Product Code: LDF Dated: September 23, 2016 Received: September 26, 2016

Dear Laura Dietch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Wilhelm
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160260

Device Name Tempo Temporary Pacing Lead

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY for K160260

General Information:

Date of Summary Preparation:	October 20, 2016
Name and Address ofManufacturer:	BioTrace Medical, Inc.831 Bransten Road, Suite LSan Carlos, CA 94070
Contact Person:	Laura N. DietchPresident and CEO
Device Trade Name:	Tempo® Temporary Pacing Lead
Common Name:	Temporary Lead
Regulation Number:	21 CFR 870.3680(a)
Regulation Name:	Temporary Pacemaker Electrode
Regulatory Class:	Class II
Classification Panel:	Cardiovascular
Product Code:	LDF

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Performance Standards: No performance standards currently exist for these devices. However, BioTrace Medical has followed, in part, FDA's Guidance for Industry: Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions (November 1, 2000). Specifically, BioTrace Medical has considered the following sections of the aforementioned guidance document during the design verification and validation testing:

Bench Testing

Bond Joint Strength
Fatigue Resistance

● Corrosion Resistance Electrical Safety Testing Biocompatibility Testing GLP Animal Studies Clinical Study

Device Description: The BioTrace Medical Tempo Temporary Pacing Lead is designed for temporary transvenous intracardiac pacing. The lead provides access to the right ventricle via either the femoral vein, subclavian vein or the internal jugular vein approach and may be shaped near the distal end to facilitate delivery. It is a radiopaque, polymeric lead featuring a balloon, active fixation, bipolar electrodes and a soft tip.

Indications for Use: The BioTrace Medical Tempo Temporary Pacing Lead is indicated for use in temporary intracardiac pacing for a maximum of seven (7) days and is designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

Predicate Device: BioTrace Medical cites the following as predicate and reference devices.

Predicate Device	Medtronic TemporaryTransvenous Pacing LeadSystem (Model 6416)	K042190
Reference Devices	C.R. Bard Temporary PacingElectrode Catheters	K800298
Design/Technological	BioTrace Medical	Predicate Device
Characteristic	(Subject Device, K160260)	(K042190)
Indications for Use	The BioTrace MedicalTempo Temporary PacingLead is indicated for use intemporary intracardiacpacing for a maximum ofseven (7) days and isdesigned to transmit anelectrical signal from anexternal pulse generator tothe heart or from the heart toa monitoring device.	The Medtronic Model 6416Temporary, Transvenous PacingLead System features an activefixation, bipolar lead and a soft-tipped lubricated guide catheter.The system is designed fortemporary intracardiac pacingand/or EGM recording.The system is disposable, fortemporary single patient use, withcontemplated implant duration of 7days or less. The lead andaccessories are supplied sterile.The lead is introducedtransvenously using the guidecatheter. Once within theappropriate chamber, the helical tipelectrode of the lead is activelyfixed into the endocardium. Afterlead placement the guide catheter isremoved by sliding it over thelead's bifurcated connector.
Lead Type	Temporary, single-use	Temporary, single-use
Lead IntroductionMethod	By cutdown or by use of apercutaneous catheterintroducer or needle cannula	By cutdown or by use of apercutaneous catheter introducer orneedle cannula
Device Compatibility	Cannula or percutaneousintroducer set toaccommodate a 6F catheter	Cannula or percutaneous introducerset to accommodate a 6F catheter
Distal Configuration	Straight with fixation(stabilizers)	Straight with fixation (helix)
Balloon	Yes	No
Lead Type	Bipolar	Bipolar
Fixation	Yes	Yes
Number of Electrodes	Two (2)	Two (2)
Single-use only	Yes	Yes
Non-pyrogenic	Yes	Yes

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Technological Comparison:

For the purpose of demonstrating the substantial equivalence of the Tempo Temporary Pacing Lead in this 510(k), BioTrace Medical has selected the Medtronic Temporary Transvenous Pacing Lead System (Model 6416), #K042190. The Tempo Temporary Pacing Lead was assessed for substantial equivalence relative to the legally marketed predicate device with respect to intended use, indications for use, and technological characteristics as summarized below.

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Testing Summary: To demonstrate intended device performance, as well as to support the substantial equivalence of the subject Tempo Temporary Pacing Lead to the predicate device, the technological and performance characteristics were evaluated by completion of the following testing:

Design Verification ●
- Bond Joint Strength
- Fatigue Resistance
- Corrosion Resistance
- Simulated Use
- Electrical Resistance
Electrical Safety Testing ●
Packaging Validation
Sterilization Validation
Shelf Life Testing (Accelerated Aging)
Biocompatibility ●
- Cytotoxicity
- Sensitization
- Irritation Reactivity
- Systemic Toxicity A
- A Subchronic Toxicity
- Genotoxicity
- A Implantation
- Hemocompatibility
- Hemolysis
- Complement Activation
- In Vivo Thrombogenicity
- Pyrogenicity
GLP Animal Testing ●
Clinical Study:

The Tempo® Study was a prospective, multicenter, non-randomized, single arm study to evaluate the safety and effectiveness of the Tempo® Temporary Pacing Lead in patients requiring temporary cardiac pacing for transcatheter aortic valve replacement, balloon aortic valvuloplasty or electrophysiology (EP) procedures. Twenty five (25) patients were enrolled in two centers. The device was evaluated for safety (freedom from pericardial effusion requiring intervention and/or echocardiographic evidence of tamponade) and technical feasibility (intracardiac

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delivery and pace capture). Additional evaluations included pace capture thresholds (PCT), success of rapid pacing, and incidence of dislodgement or sustained ventricular arrhythmias (>30 seconds). Transthoracic echocardiograms were obtained at baseline and 24 hours after lead removal. Follow up was to 30 days.

The safety endpoint was met in all patients (100%) with no device-related adverse events. The technical feasibility endpoint was met in 23 patients (92%). No patient had a sustained ventricular arrhythmia or lead dislodgement. Average final procedural PCT was 0.7±0.5 mA. Rapid pacing was successful in all cases, with no loss of pace capture. In 5 patients the lead was successfully used postprocedure.

This first-in-human study demonstrates that the Tempo Lead is safe and effective for temporary cardiac pacing.

The results from these tests and studies demonstrate that the technological and performance characteristics of the subject Tempo Temporary Pacing Lead are adequate for its intended use and ensure the subject device can perform in a manner equivalent to devices currently on the market with the same intended use.

Conclusion: The data and information presented within this submission (including in vitro bench, in vivo animal testing and the clinical study) support a determination of substantial equivalence of the Tempo Temporary Pacing Lead to marketed temporary pacing leads.

Regulation Number and Section

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.

(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.